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Food & drug recall · FDAOctober 17, 2023Highest risk

VistaPharm LLC — Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles

Stop taking it and tell your doctor or pharmacist.

Why this is on The Recall Registry: This is a consumable product recalled for what is inside it. It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

What’s wrong

Failed Excipient Specifications: high content of ethylene glycol (EG)

The Recall Registry rates this highest risk — Contains a chemical that is not safe to swallow at any dose.

What to do

Stop taking it, and tell your doctor or pharmacist that you have been taking it. It contains a drug ingredient that is not on the label, so they need to know — it can interact with medication you are already on.

Who to contact: Recalling firm: VistaPharm LLC

The product

Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08

Details

Units affected
Prod Lot number 22ZKY1, EXP 11/27/23, 600 bottles dist; 22ZMC1 EXP12/21/23 600 bottles; 22ZTP1 EXP 03/29/24 588 bottles; 23ZAD1 EXP 07/07/24 564 bottl
Recall date
October 17, 2023
Brand
VistaPharm LLC
Model, lot or SKU numbers
Lot #: 22ZKY1, Exp. 11/27/2322ZMC1, Exp. 12/21/2322ZTP1, Exp. 03/29/2423ZAD1, Exp. 07/07/24.
Where it was distributed

Nationwide USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “VistaPharm LLC — Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz. (236.5 mL) HDPE bottles, Manufactured for: VistaPharm, Inc., Largo, FL 33771, UAS, NDC 66689-330-08”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Over-the-counter & supplements

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